Stent Testing

Each year more than a million people in the United States have coronary angioplasty. A stent placed in an artery as part of the angioplasty restores blood flow through narrowed or blocked arteries. Stents - a small mesh tube - help prevent the arteries from becoming narrowed or blocked again and are usually made of metal mesh, but sometimes they're made of fabric. Fabric stents, also called stent grafts, are used in larger arteries.



In partnership with Machine Solutions Inc. (MSI), we provided a solution to test stents during expansion and compression. A typical test can be observed in the video that features a single column system and the RX fixture with MSI’s proprietary segmental compression mechanism. You'll see that the data acquisition during the test is handled by materials testing software that provides radial hoop strength and radial stiffness results.

We know it's important to develop systems that are in accordance with not only ASTM standards, but also international testing recommendations. Here's a few we kept in mind for stents testing:
• The FDA guidance document titled “Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems”
• ISO Standard 25539-1:2003(E) Titled “Cardiovascular implants – Endovascular devices”
• ISO/TS 15539:2000(E) Titled “Cardiovascular implants – endovascularprostheses”